Effect of Methotrexate Discontinuation on Immunogenicity of Shingrix in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Cell-mediated immunity (CD4+ and CD8+ T cell against herpes zoster)
研究概览
简要总结
The goal of this clinical trial is to learn if methotrexate discontinuation affect on immunogeneity of shingrix in RA patients. The main questions it aims to answer are:
Discontinuation of methotrexate after shingrix immunization increase efficacy of the vaccine in patients with RA ?
Researchers will compare humoral and cell-mediated immunity against herpes zoster in RA patients who are vaccinated by shingrix, and compare these immunity between RA patients with MTX discontinuation and MTX continuation groups.
Participants will:
Vaccinated with shingrix twice. MTX continuation group will keep taking MTX after shingrix vaccination, whereas MTX discontinuation group will stop MTX for 2 weeks after shingrix vaccination.
Visit the clinic at baseline (first shingrix vaccination), 2 months later for 2nd shingrix vaccination, then 3 & 6 months later from baseline to achieve blood sample.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fulfill 2010 ACR/EULAR classification criteria for rheumatoid arthritis
- •age over 19 years
- •methotrexate user
- •agree for vaccination with shingrix
排除标准
- •have other form of inflammatory arthritis or autoimmune-mediated disease
- •malignancy, current infection, pregnancy
研究组 & 干预措施
MTX discontinuation
methotrexate stop for 2 weeks after each shingrix vaccination
干预措施: Methotrexate (Drug)
MTX continuation
干预措施: Methotrexate (Drug)
结局指标
主要结局
Cell-mediated immunity (CD4+ and CD8+ T cell against herpes zoster)
时间窗: baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination
次要结局
- , Humoral immunity (anti-VZV antibody, anti-gE antibody)(baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination)
研究者
Hong Ki Min
Assistant Professor
Konkuk University Medical Center